Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm. The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 180 days, consisting of a revision prosthesis implanted at Stage 2, absence of periprosthetic joint infection (PJI), absence of continued antibiotic therapy for treatment or prophylaxis of PJI, absence of revision surgery and absence of mortality. Secondary objectives are to evaluate overall success at 365 days, overall safety of the VT-X7 procedure, quality of life (QoL), and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
Seven-day local antibiotic irrigation (alternating vancomycin hydrochloride and tobramycin sulfate) via the temporary VT-X7 Knee or Hip Spacer.
Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis.
Administration of at least 6 weeks of systemic antibiotics post-Stage 1 surgery followed by a 2-week antibiotic holiday before the Stage 2 surgery. After Stage 2 surgery, administration of at least 12 weeks of systemic antibiotics. Antibiotics will be selected by the treatment provider based on the infecting organism and administered per national and local treatment guidelines.
After Stage 2 surgery, administration of at least 12 weeks of systemic antibiotics. Antibiotics will be selected by the treatment provider based on the infecting organism and administered per national and local treatment guidelines.
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Harbor UCLA Medical Center
Los Angeles, California, United States
Kennedy White Orthopaedic Center
Sarasota, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Covenant Medical Center
Saginaw, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
NYU Langone Health
New York, New York, United States
OrthoCarolina
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
...and 9 more locations
Overall Treatment Success
* Stage 2 revision prosthesis implanted and * Absence of PJI post-Stage 2 and * Absence of continued antibiotic therapy for treatment or prophylaxis of PJI and * Absence of revision surgery of the affected joint pre- and post-Stage 2 and * Absence of mortality.
Time frame: 180 days
Overall Treatment Success
* Stage 2 revision prosthesis implanted and * Absence of PJI post-Stage 2 and * Absence of continued antibiotic therapy for treatment or prophylaxis of PJI and * Absence of revision surgery of the affected joint pre- and post-Stage 2 and * Absence of mortality.
Time frame: 365 days
Adverse Event Rate
Comparison of the cumulative proportion of subjects with reported adverse events between the study arms.
Time frame: 365 days
Quality Adjusted Life Years
Comparison of Quality Adjusted Life Years between the study arms as estimated by EQ-5D-3L.
Time frame: 365 days
Survival
Comparison of the survival between the study arms.
Time frame: 365 days
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